COSMETIC

Classification of Masseter Hypertrophy for

Tailored Botulinum Toxin Type A Treatment
Yun Xie, M.D.
Jia Zhou, M.D.
Haizhou Li, M.D.
Cheng Cheng, M.D.
Tanja Herrler, M.D.
Qingfeng Li, M.D., Ph.D.
Shanghai, Peoples Republic of China;
and Munich, Germany

Background: Botulinum toxin type A has been increasingly used to improve

the lower face contour in masseter hypertrophy. Different dosages and injection techniques are suggested in the literature, but the ideal approach remains
unclear. This study aimed to establish an objective masseter classification method for a personalized botulinum toxin type A injection protocol.
Methods: A combination of clinical palpation, B-mode ultrasound examination, and anatomical dissection studies was applied to classify the masseter
regarding bulging type on clenching and muscle thickness in a normal population and in patients desiring reduction of masseter hypertrophy. Based on
these findings, a tailored botulinum toxin type A injection protocol was set
up and evaluated in a prospective clinical study regarding masseter thickness,
facial measurements, patient satisfaction, and complications.
Results: A total of 504 masseters were classified into five bulging types (minimal,
mono, double, triple, and excessive) and three degrees of thickness (<10 mm,
10 to 14 mm, and >14 mm). Two hundred twenty cases were treated using individualized botulinum toxin type A injection dosages (20 to 40 units) and sites
(one to three per muscle); the treatment was applied in 220 cases, according
to the respective classification. Masseter thickness decreased significantly, from
12.9 2.9 mm to 8.7 1.7 mm, 3 months after injection (p < 0.01). The initial
ratio of the widest width of the lower face to the intercanthal distance (3.3
0.18) was also significantly reduced (3.0 0.2; p < 0.01). The overall patient
satisfaction rate was 95.9 percent. No serious complications occurred..
Conclusions: The present study provides the scientific basis for individualized
botulinum toxin type A injection for masseter hypertrophy. This protocol allowed for reduction of injection dosage and complication rates, and showed
beneficial clinical effects in terms of significantly reduced masseter volume and
improved lower face contour. (Plast. Reconstr. Surg. 134: 209e, 2014.)
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

asseter hypertrophy may cause a prominent mandibular angle, resulting in an

unattractive wide contour of the lower
face. Etiologic factors include mental stress and
bruxism, but also work hypertrophy from chewing.1 In 1994, Moore and Wood introduced botulinum toxin type A injection of the hypertrophic
masseter to treat functional problems.2 Later,
From the Department of Plastic and Reconstructive Surgery,
Shanghai Ninth Peoples Hospital Affiliated to Shanghai
Jiao Tong University School of Medicine; and Hand, Plastic, and Aesthetic Surgery, Department of General, Trauma,
Hand, and Plastic Surgery, University of Munich.
Received for publication October 7, 2013; accepted December
30, 2013.
The first two authors contributed equally to this work as first
authors.
Copyright 2014 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0000000000000371

ijsdijk et al. began to use botulinum toxin type

R
A for aesthetic volume reduction of the hypertrophic masseter.3 In contrast to conventional surgery,
botulinum toxin type A injection is a minimally
invasive technique, and is easy and safe to handle.4
Especially in Asian populations that tend to have
a wider contour of the lower face,57 it has become
a first-choice treatment for masseter hypertrophy.
A review of the literature showed that a criterion standard for the use of botulinum toxin type
A in the treatment of masseter hypertrophy is
lacking. In 2005, Choe et al. suggested that more
than 20 units of botulinum toxin type A should
Disclosure: None of the authors has any commercial
associations or financial interest in any of the drugs,
products, or instruments used in this study. All of
the authors conform to the Declaration of Helsinki.

www.PRSJournal.com

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Plastic and Reconstructive Surgery August 2014

be injected if masseter thickness exceeded 10mm
(Botox; Allergan, Inc., Irvine, Calif.).8 In the same
year, Kim et al. proposed the application of 100 to
140 units for a masseter thickness of 10 to 16mm
(Dysport; Ipsen Ltd, Slough, United Kingdom).5
In a study investigating the influence of botulinum toxin type A injections on the parotid gland,
Kwon et al. recommended the injection of 25 units
per muscle at two injection sites (BTX-A; Lanzhou
Institute of Biological Products, Lanzhou, Peoples
Republic of China).9 Recently, Gaofeng et al. proposed 30 to 50 units per side (BTX-A),10 whereas
Jaspers et al. used 36 units of botulinum toxin type
A (Botox) injected at three sites per muscle.11
For a standardized treatment approach, an
appropriate assessment method of the pretherapeutic status is pivotal. However, the anatomy of
the masseter has not been precisely defined yet
and a classification method is lacking. Thus, the
extent of masseter hypertrophy has not been considered in clinical trials, resulting in varying dosage and application suggestions. As to the injection
technique, partitioned injection at three different
sites was used most frequently, but the location of
the ideal injection sites remains controversial.9,10
In the present study, we first classified the masseter muscle based on the findings from (1) a
large-sample prospective study involving clinical
and ultrasound examination and (2) anatomical
dissection studies. The classification served as the
basis for a personalized botulinum toxin type A
injection protocol that was evaluated in a prospective clinical study regarding its safety and efficacy
in the treatment of masseter hypertrophy.

PATIENTS AND METHODS

Classification of the Masseter Muscle
Study Design
A total of 252 cases (504 masseters) were investigated in our clinic between March of 2011 and
December of 2011 using clinical and ultrasound
examination. The study cohort included 24 men
(age range, 19 to 30 years; mean, 23.5 years) and
228 women (age range, 18 to 42 years; mean, 22.7
years). Seventy-four cases had a history of botulinum toxin type A treatment, but not within at
least a 1-year interval to exclude any impact of
botulinum toxin type A on the masseter. The rest
of the patients had never undergone botulinum
toxin type A injection.
Clinical Examination
Clinical examination was performed in all
patients, including inspection and palpation of

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the masseter on resting and clenching. The different bulging types of the contracted masseter were
identified based on palpation, because morphologic assessment may be disguised by subcutaneous
adipose tissue. B-mode ultrasound (Mindray M5;
Mindray Medical International Ltd., Shenzhen,
Peoples Republic of China) was used to measure
masseter thickness. The patient was seated face
to face on the right hand side of the investigator.
The masseter was scanned on clenching from the
bottom upward with the detector placed parallel
to the inferior border of the mandible. The thickest part of the masseter was found in the area
between the inferior border of the mandible and
the virtual line drawn from the angulus oris to the
ear lobe. Masseter thickness was determined in
an ultrasound cross-sectional view at this point on
contraction and resting of the muscle.
Anatomical Study of the Masseter Muscle
Dissection studies of the masseter area in three
fresh corpses were performed to elucidate the anatomical correlates of the different bulging types.
The layers of the masseter and the branching and
course of the masseteric nerve were explored.
Evaluation of Tailored Botulinum Toxin Type A
Injection Protocol for the Treatment of Masseter
Hypertrophy
Study Design
A total of 220 cases were treated in our institution between January of 2012 and June of 2012.
There were 15 men (age range, 19 to 30 years; mean
age, 24.1 years) and 205 women (age range, 18 to
38 years; mean age, 21.5 years). All patients sought
treatment for narrowing the lower face contour.
Botulinum Toxin Type A Treatment
All patients were treated according to the
respective classification of masseter bulging type
and thickness using botulinum toxin type A from
Hengli (Lanzhou Institute) that exhibits equal efficiency compared with Botox. Each patient was followed up by telephone call within 2 to 48 weeks.
Clinical follow-up at 1, 2, 3, and 4 months after
botulinum toxin type A treatment was achieved in
40 patients. Standard photography documentation
was performed at each visit. Patients were instructed
to immediately present for an unscheduled followup if adverse effects occurred in the meantime.
Clinical Evaluation
The therapeutic outcome was evaluated using
ultrasound examination and morphometric analysis.
Sonography was performed by the same investigator

Volume 134, Number 2 Masseter Hypertrophy and Botulinum Toxin

in all patients in a blinded manner. Morphometric
analysis based on standard patient photographic
documentation was conducted by a plastic surgeon
not involved in botulinum toxin type A injection.
The ratio of the widest part of the lower face to the
intercanthal distance was calculated using Photoshop 7.0 (Adobe Systems, Inc., San Jose, Calif.) to
compare the therapeutic effect. All complications
were recorded. Patients were called for a follow-up
interview to assess their impression regarding the
therapeutic effect (i.e., remarkable effect, effect, or
no obvious effect) and patient satisfaction.
Statistical Analysis
The data were analyzed using the paired t test to
compare masseter thickness and the morphometric ratio of the widest part of the lower face to the
intercanthal distance before and after treatment
using SPSS 12.0 (SPSS, Inc., Chicago, Ill.). Values
of p < 0.05 were considered statistically significant.

RESULTS
Bulging Types of the Contracted Masseter
Muscle
A total of 504 masseters were examined by palpation and divided into five bulging types on contraction (Table1). Minimal bulging (type I) was
found in 21.4 percent. A single longitudinal bulge
was palpated in 33.1 percent and classified as
mono bulging type (type II). Type III showed two
longitudinal bundles of equal or differing height
(28.4 percent). Triple bulging (type IV), characterized by three longitudinal bulges, was found
in 6.0 percent. In 11.1 percent, a single excessive
bulge was palpable (type V). It is important to
note that the bulging types were assessed based
on palpation. However, in selected cases, they may
be morphologically distinct (Fig.1).
Masseter Thickness Based on B-Mode
Ultrasound Examination
The results from B-mode ultrasound examination were consistent with the clinical classification.
The cross-sectional views showed that different types
of bulging occur on masseter contraction (Fig.2).

The average thickness measured in 504 masseters

was 12.3 2.7mm. Data showed a normal distribution (Fig.3). Masseter thickness was classified
as mild (lower quartile, <10mm), moderate (10to
13.9mm), and severe (upper quartile, >14mm)
and varied between the different masseter bulging
types (Table2). Statistical analysis showed that the
thickness of type V (15.6 1.8mm) was significantly
greater than in the four other types (p<0.01). The
thickness of type IV (13.1 2.2mm) was also significantly more than in type I (12.0 1.2mm; p<0.05)
and type II (11.8 2.2mm; p<0.05). No other significant differences were found for the remaining
groups (Fig.4).
Anatomical Dissection Studies
Masseter dissection studies were performed
to gain a comprehensive understanding about
the different bulging types and their anatomical
correlative. The masseter was found to be a threelayer skeletal muscle consisting of superficial,
middle, and deep layers. The myofibers within
these layers were arranged in different directions.
The superficial layer arose from the anterior part
of the zygomatic arch and passed backward and
downward to be inserted into the masseter tuberosity. The thinner middle layer arose from the
posterior segment of the zygomatic arch and traveled downward to the front to be inserted into the
masseter tuberosity. The deep layer arose from the
posterior part of the zygomatic arch, and passed
backward and downward to be inserted into the
masseter tuberosity. These three layers were separate in the upper two-thirds of the mandibular
ramus and intimately fused together in the lower
third part. The corresponding nerve trunk of
the masseter entered the muscle from its upper
edge. Then, it separated into three primary nerve
branches and entered the masseter in the superficial, middle, and deep layers, respectively (Fig.5).
Tailored Botulinum Toxin Type A
Injection Protocol
Location of Injection Sites
The setup of a personalized treatment strategy for botulinum toxin type A injection required

Table 1. Classification of the Contracted Masseter Muscle Regarding Bulging Type

Type
I
II
III
IV
V

Bulging

Detailed Description

No. (%)

Minimal
Mono
Double
Triple
Excessive

Even masseter contraction, no obvious bulging palpable

Local single longitudinal bulge
Two separate longitudinal bulges of equal or differing height
Three longitudinal bulges
Massive single bulge

108 (21.4)
167 (33.1)
143 (28.4)
30 (6.0)
56 (11.1)

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Plastic and Reconstructive Surgery August 2014

Fig. 1. Morphologic aspect of the five types of masseter bulging on resting and
clenching. (Above) Type I, minimal; (second row) type II, mono; (third row) type III,
double; (fourth row) type IV, triple; (below) type V, excessive.

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Volume 134, Number 2 Masseter Hypertrophy and Botulinum Toxin

Fig. 2. Sonographic cross-sectional views of the five masseter bulging types. (Left) Type I, minimal; (second from left) type II, mono;
(center) type III, double; (second from right) type IV, triple; (right) type V, excessive.

Fig. 3. Masseter thickness assessed by ultrasound measurements. The data show

a normal distribution.

Table 2. Variation in Masseter Thickness between the

Different Bulging Types
Thickness
Bulging Type
I
II
III
IV
V

Range (mm)

Mean (mm)

5.117.9
7.118.7
5.218.6
8.018.3
14.019.9

12.0 1.2
11.8 2.2
12.4 2.7
13.1 2.2
15.6 1.8

careful consideration regarding injection dosage

and number and location of injection sites. Botulinum toxin type A acts by means of muscle denervation by blocking the presynaptic membrane of
the nerve endings at the motor end plate. Therefore, the area of the motor end plate that coincided with the most prominent part of the muscle
bulge appeared to be the ideal injection site.
Injection Dosage
The injection dosage was determined by
masseter thickness. Thickness less than 10mm
was considered mild hypertrophy requiring an injection dosage of 20 to 25 units per

masseter. Moderate hypertrophy with a thickness between 10 and 13.9mm demanded a

dosage of 25 to 30 units per masseter. Thickness greater than 14mm showed severe hypertrophy; in this case, a dosage of 30 to 40 units
was used.
Number of Injection Sites
In mild masseter hypertrophy or normal masseter with bulging type I (minimal), treatment
consisted of a single injection of 20 to 25 units of
botulinum toxin type A. In moderate hypertrophy, the drug was distributed evenly across the
bulge surface through two injection sites using
12.5 to 15.0 units of botulinum toxin type A per
site. For severe hypertrophy, botulinum toxin type
A was injected at three different sites and distributed evenly across the bulge surface.
In mono bulging type (type II), the injection
was placed at the most prominent point of the
bulge. The total dosage per muscle was dependent on the degree of hypertrophy. In severe
hypertrophy and a bulge length of greater than
2cm, botulinum toxin type A was applied at two
sites per masseter.

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Plastic and Reconstructive Surgery August 2014

Fig. 4. Differences in masseter thickness among the five types of masseter bulging.

Fig. 5. Anatomical dissection of the masseter muscle. The masseter consists of three layers: superficial (S), middle (M), and deep
(D). The myofibers within the layers are arranged in different directions.

For double bulging masseters (type III), botulinum toxin type A was applied at both bulging points.
The total dosage per masseter was determined by
the extent of hypertrophy. The dosage per injection
site was chosen according to the ratio of the two
bulges in height. In severe hypertrophy (i.e., a bulge
length >2cm), the bulge was injected at two sites.
Masseter muscles of triple bulging type
(typeIV) received botulinum toxin type A injection at the most prominent point on each of the
three bulges. The total dosage per masseter was
selected depending on the hypertrophic degree
of the most prominent bulge. Dosage per injection site was partitioned in analogy to the ratio of
the three bulges in height.
In excessive bulging (type V), the masseter
was treated at the most prominent point of the
bulge using three injections. The total dosage per

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Table 3. Tailored Botulinum Toxin Type A Injection

Protocol*
Bulging Type
Thickness (mm)

II

III

IV

Total BTX-A
Dosage
(units)

Mild (<10)
Moderate
(1013.9)
Severe (>14)

2025

2
3

1
12

2
23

3
3

2530
3040

BTX-A, botulinum toxin type A.

*The total botulinum toxin type A dosage and the number of injection sites per masseter are determined by the respective masseter
type and thickness.

side was 30 to 40 units, 50 percent of the dosage

was applied at the highest point, and 25 percent
each was injected adjacent to this site in a triangular configuration. Table3 shows the personalized
botulinum toxin type A treatment at a glance.

Volume 134, Number 2 Masseter Hypertrophy and Botulinum Toxin

Fig. 6. Masseter thickness measured before and 1, 2, 3, and 4 months after injection.

Treatment Effects
Follow-up examinations at 1, 2, 3, and 4 months
after treatment were performed in 40 cases using
B-mode ultrasonic examination and standard
photographic documentation. Average masseter
thickness before injection was 12.93 2.91mm.
Compared with preinjection data, a significant
reduction in thickness was found during followup after 1 month (11.33 2.16mm; p < 0.05), 2
months (9.56 1.8mm; p < 0.01), 3 months (8.68
1.71mm; p < 0.01), and 4 months (9.32 1.73mm;
p < 0.01) after injection (Fig.6). The minimal value
of mean masseter thickness was observed 3 months
after botulinum toxin type A injection. The ratio of
the widest part of the lower face to the intercanthal
distance before injection was 3.3 0.18 compared
with 3.03 0.022 at 3 months after injection. The
changes were statistically significant (p < 0.01).
Complications occurred in 20 of 220 cases (9.1
percent) as assessed by both interview and clinical
follow-up. The complication rate was 60 percent
among patients who received higher dosages of botulinum toxin type A. Among the adverse events
dizziness, headache, allergic reaction, insufficient
treatment result, abnormal mastication, abnormal activities of the temporomandibular joint,
Table 4. Complications following Tailored Botulinum
Toxin Type A Injection for Masseter Hypertrophy
Complication
Dizziness
Headache
Allergic reaction
Inadequate injection
Abnormal mastication
Abnormal activities of
temporomandibular joint
Paradoxical bulging
Concave below zygomatic arch
Disappearance of dimple
Unnatural smile
Total

No. of
Adverse Events
2
1
3
5
2
2
3
7
2
6
33

occurrence of an extra bulge (paradoxical bulging),

formation of a concave below the zygomatic arch,
disappearance of dimples, and unnatural smile
unnatural smile was the most frequent (Table4).
In follow-up interviews, 138 patients (62.7 percent)
reported a remarkable effect, 73 patients (33.2 percent) observed an effect, and nine patients (4.1 percent) did not notice an obvious effect. The patient
satisfaction rate was 95.91 percent.

CASE REPORTS
Case 1: Symmetric Severe Masseter Hypertrophy,
Bulging Type IV
A 31-year-old female patient presented with severe bilateral
masseter hypertrophy (thickness, 16.9mm). Masseter contraction showed a triple bulging type (type IV). A total of 40 units
of botulinum toxin type A was injected per muscle at three different sites (5, 30, and 5 units). Three months after injection,
masseter thickness decreased to 9.8mm on the left side and to
8.4mm on the right (Fig.7).

Case 2: Asymmetric Moderate/Severe Masseter

Hypertrophy, Bulging Type III/II
A 28-year-old male patient sought treatment for asymmetric
masseter hypertrophy. Before injection, the left masseter exhibited
moderate hypertrophy (thickness, 13.4mm) associated with double
bulging (type III). The right masseter was characterized by severe
hypertrophy (thickness, 15.5mm) with mono bulging (type II).
The left side was injected with 30 units of botulinum toxin type A at
two sites, whereas 40 units was applied on the right masseter at two
sites (20 and 20 units). Three months after injection, masseter thickness was 11.2mm on the left side and 11.5mm on the right (Fig.8).

DISCUSSION
The commonly used botulinum toxin type A
injection techniques for the treatment of masseter
hypertrophy aim at evenly distributing the drug
within the masseter muscle. As a consequence,
higher dosages and injection volumes are required
to obtain the desired therapeutic effect. This may
not only be associated with a higher rate of adverse
reactions such as paradoxical bulging, but might

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Plastic and Reconstructive Surgery August 2014

Fig. 7. Case 1. Symmetric severe masseter hypertrophy, bulging type IV.

Fig. 8. Case 2. Asymmetric masseter hypertrophy. Moderate hypertrophy of the left masseter
bulging type III in combination with severe hypertrophy bulging type II on the right side.

also raise the possibility of drug resistance.12,13 Tailored botulinum toxin type A injection is a novel
approach for reducing injection dosage and volume
while maintaining the optimal therapeutic effect.
In clinical practice, we found that bulging characteristics of the masseter vary on clenching. In the
present study, we identified five different bulging
types of the contracted masseter: minimal, mono,
double, triple, and excessive (Fig.9). Dissection
studies revealed that the masseter consists of multiple layers that exhibit different directions of muscle contraction. These muscle layers are innervated
by separate nerve branches that originate from the
nervus massetericus. Strikingly, the localization of

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the most prominent part of the muscle bulge was

consistent with the distribution region of the nervus
massetericus in the central V of the lower one-third
region.14,15 Because botulinum toxin type A exerts
its mode of action by targeting the motor end plate,
an injection close to the nerve endings directly at
the site of action would allow for reduced injection
dosage and volume and a more limited dispersion
region.13,16,17 We therefore chose the most prominent point of the bulging muscle as the ideal injection site. The dosage was adapted according to the
static thickness of the masseter, because muscle
thickness correlates with muscle force and thus the
required dosage of botulinum toxin type A.

Volume 134, Number 2 Masseter Hypertrophy and Botulinum Toxin

Fig. 9. Schematic diagram of the five types of masseter contraction bulging in a cross-sectional view. The different bulging types
are a result of differing contraction of the three masseter layers.

In the present study, we established and evaluated a tailored botulinum toxin type A injection
protocol for varying masseter thicknesses and different hypertrophy bulging types, referring to a
prospective clinical trial that suggested 20 units as
the minimal effective dosage.8 In a prospective clinical trial, we found that tailored botulinum toxin
type A treatment for masseter hypertrophy led to
a significant decrease in muscle thickness. Moreover, the contour of the lower face improved after
injection, with an overall patient satisfaction rate as
high as 95.91 percent. The most distinct therapeutic effects were seen at 3 months after injection. It
is important to note that complications observed in
the present study were related to high dosages and
a wide dispersion region. Complications such as
zygomatic and buccal depression, unnatural smile,
disappearance of dimples, and paradoxical bulging
were consistent with previous reports.12,14,18
The present study is limited by a loss of patients
to follow-up. A comparative study regarding the different masseter bulging types and degrees of thickness with close follow-up examinations would allow
for a deeper understanding and establishment of a
more differentiated treatment protocol. Improving
therapeutic outcome and reducing complication
rates are the major objectives. It will be essential to
continue accumulating clinical data to further optimize the therapeutic strategy of personalized botulinum toxin type A injection for masseter hypertrophy.
Qingfeng Li, M.D., Ph.D.
Department of Plastic and Reconstructive Surgery
Shanghai Ninth Peoples Hospital Affiliated to Shanghai
Jiao Tong University School of Medicine
639 Zhizhaoju Road
Shanghai 200011, Peoples Republic of China
dr.liqingfeng@yahoo.com

PATIENT CONSENT

Patients provided written consent for the use of their

images.

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